CClinicalTrials.gg
CompletedNCT04837846MINDS-CADUpdated Nov 12, 2024

Multicenter Study Into Individualized Scanning for Coronary Artery Disease

An observational study in Coronary Artery Disease, sponsored by Medical University of South Carolina. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-12.

Sponsored by Medical University of South Carolina · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
60
Ages
18 Years and older
Sex
All
01

Study summary

To evaluate intravascular attenuation of the coronary arteries and image quality in an individualized scan and CM injection protocol whereas both scan and injection parameters are tailored to the individual patient in a North American, European and Asian patient population.

To evaluate the radiation dose and contrast media dose of this individualized approach for CCTA in an American, European and Chinese patient population.

To evaluate the injection parameters required for an average American, European and Chinese patient population.

02

Conditions studied

03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's enrollment of 60 is below the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Medical University of South Carolina is the lead sponsor of 852 studies on the registry; 165 are open to participants now.

Of its 128 completed or terminated interventional studies of FDA-regulated products, 101 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adults with complaints of angina, referred for a clinically indicated CCTA scan

Inclusion criteria

  • To be eligible for the study: (All answers must be "YES" for subject to be eligible.)

    1. Referred for a clinically indicated CCTA scan.
    2. Patient aged older than 18.
    3. Subject must provide written informed consent prior to any study-related procedures being performed.
    4. Subject must be willing to comply with all clinical study procedures.
    5. Atypical or typical complaints of angina.
    6. No previous cardiovascular history.
    7. Possibility of 'flash' mode scan; patient heart rate below 70 beats per minute and regular rhythm.

Exclusion criteria

Exclusion Criteria:

  • The presence of the following excludes subjects from the study: (All answers must be "NO" for subject to be eligible.)

    1. Contraindications for CT coronary angiography, including:

      1. Inability to perform a breath hold for at least the expected scan time
      2. Unstable angina
      3. Hemodynamic instability
      4. Known history of CAD
      5. Pregnancy
      6. Renal insufficiency (defined as Creatinine \<1.5 mg/dL or GFR\<30 mL/min)
      7. Iodine allergy
    2. Insufficient cannula venous access (preferred 18G, minimal 20G cannula)
    3. Subject has an acute psychiatric disorder.
    4. Subject is unwilling to comply with the requirements of the protocol.
    5. Subject has previously entered this study.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
60 participants (actual)
Patient registry
No

Groups and cohorts

  • Prospective CCTA Arm

    Other: Differing Tube Voltage Administration

Interventions

  • OtherDiffering Tube Voltage Administration

    Subjects will undergo CCTA utilizing a scan and contrast media injection protocol that will be tailored to individual body habitus.

06

What researchers measure

Primary outcomes

  1. Evaluation of Intravascular Attenuation

    To measure the amount of Hounsfield units in different anatomical structures produced by an amount of contrast media. Using Hounsfield units coupled with image quality to determine if a scan of diagnostic value has been attained.

    Time frame: At time of CCTA scan

07

Study locations

1 site
  • Medical University of South Carolina
    Charleston, South Carolina 29425, United States
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04837846
Lead sponsor
Medical University of South Carolina
Responsible party
Sponsor
First posted
Apr 8, 2021
Start date
Mar 29, 2021
Primary completion
Apr 5, 2024
Completion
Apr 5, 2024
Last update
Nov 12, 2024

Study contacts

Joseph U. Schoepf, MD
principal investigator · Medical University of South Carolina

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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